Reported Dec 6, 2017 · Terminated

Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC…

Zydus Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only
  • Manufactured byCadila Healthcare Ltd, Ahmedabad
  • India Distributed byZydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
Lot codes and dates
    • a) Z701308
    • b) Z701309
    • c) Z701310 exp April 2019
Amount recalled
19812 bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 1, 2020 · Data as of Sep 19, 5:01 PM UTC

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